title: Rationale and design of the INFUSE-AMI study: A 2 × 2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction.
abstract: BACKGROUND
  Whether thrombus aspiration and local glycoprotein IIb/IIIa administration reduce infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has not been established in multicenter studies.
  
  
  METHODS
  INFUSE-AMI is a multicenter, open-label, controlled, single-blind randomized study enrolling 452 subjects with anterior STEMI and an occluded proximal or mid-left anterior descending artery with thrombosis in myocardial infarction 0, 1, or 2 grade flow undergoing primary PCI with bivalirudin anticoagulation. Subjects are randomized in a 2 × 2 factorial to one of the following 4 arms: (1) local infusion of abciximab using the ClearWay RX Local Therapeutic Infusion Catheter (ClearWay, Atrium Medical Corp, Hudson, NH) after aspiration with a 6F Export Aspiration Catheter (Medtronic, Inc, Minneapolis, MN), (2) local infusion of abciximab using the ClearWay RX Infusion Catheter and no aspiration, (3) no local infusion of abciximab and aspiration with a 6F Export Aspiration Catheter, or (4) no local infusion of abciximab and no aspiration. The primary end point is infarct size (percentage of total left ventricular mass) at 30 days measured by cardiac magnetic resonance imaging. Other secondary end points include microvascular obstruction by cardiac magnetic resonance imaging at 5 days, ST-segment resolution, angiographic myocardial perfusion, thrombus burden, angiographic complications, and clinical events through 1-year follow-up. Safety end points include major and minor bleeding.
  
  
  CONCLUSIONS
  INFUSE-AMI is testing the hypothesis that the intracoronary administration of an abciximab bolus with or without thrombus aspiration before stent implantation compared to no infusion with or without thrombus aspiration reduces infarct size among patients undergoing primary PCI for anterior STEMI who are treated with bivalirudin.
authors.affiliation: Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. mgibson@perfuse.org
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.forename: Akiko
authors.initials: A
authors.lastname: Maehara
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Jochen
authors.initials: J
authors.lastname: Wohrle
authors.forename: Tom
authors.initials: T
authors.lastname: Stuckey
authors.forename: Rajesh
authors.initials: R
authors.lastname: Dave
authors.forename: David
authors.initials: D
authors.lastname: Cox
authors.forename: Cindy
authors.initials: C
authors.lastname: Grines
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Gabriel
authors.initials: G
authors.lastname: Steg
authors.forename: Helen
authors.initials: H
authors.lastname: Parise
authors.forename: Steven D
authors.initials: SD
authors.lastname: Wolff
authors.forename: Ecaterina
authors.initials: E
authors.lastname: Cristea
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000077284:Abciximab; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D000991:Antithrombins / Q000627:therapeutic use; D054059:Coronary Occlusion / Q000652:urine; D003328:Coronary Thrombosis / Q000601:surgery*; D023381:Endpoint Determination; D006629:Hirudins; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D007261:Infusions, Intra-Arterial; D019028:Magnetic Resonance Imaging, Cine; D009203:Myocardial Infarction / Q000473:pathology / Q000628:therapy*; D018579:Patient Selection; D010446:Peptide Fragments / Q000627:therapeutic use; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012107:Research Design; D017131:Thrombectomy / Q000379:methods
chemical_list: D000911:Antibodies, Monoclonal; D000991:Antithrombins; D006629:Hirudins; D007140:Immunoglobulin Fab Fragments; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D011994:Recombinant Proteins; C074619:bivalirudin; D000077284:Abciximab